The present invention relates to a device for avoiding packaging machine contamination when processing and packaging human tissue, and more particularly, to an isolation pouch for avoiding cross contamination by isolating the human tissue from the sealer packaging machine components during the sealing operation.
The basics of medical sealer devices are well known. Generally, medical sealers (as these devices are known) require four basic components: a solenoid or pneumatic piston for applying pressure, a jaw mechanism for holding the medical package, a heating element for melting the package material, and a processor for controlling the mechanical components and for communicating with other devices (or with the internet). Medical sealer devices operate by the solenoid or pneumatic piston engaging the jaw mechanism to pull an upper jaw down onto a lower jaw in order to apply a predetermined pressure to a flexible medical package (a medical package may also be referred to as a pouch). The heating element is then flash heated to a predetermined temperature (a temperature required to melt the packaging material) for a predetermined time to melt the packaging material; wherein the processor may determine the predetermined temperature and the predetermined time. The jaw mechanism is held closed for a predetermined cool time (also determined by the processor), after which the package may be safely removed from the medical sealer device.
When using a sealer machine to seal medical pouches containing human tissue, cross contamination between samples or between donors is a major problem that must be avoided. Currently utilized procedures for avoiding contamination involve aggressively wiping down sealer machine components with antimicrobial disinfectants and the like. But such wipe-down procedures can damage vital sealer machine components and therefore decrease the life cycle of an expensive and necessary piece of equipment.
There is a need, therefore, for alternative means to avoid cross contamination during processing of human tissue samples. The herein disclosed human tissue isolation pouch avoids cross contamination in an entirely new way. By allowing for indirect heating/sealing of the medical pouch through the isolation pouch, the human tissue remains isolated from the sealer jaws at all times during the sealing operation. The sealer jaws are not exposed to the human tissue, and thus the sealer jaws cannot contaminate subsequent human tissue samples and do not need to be wiped down with damaging antimicrobials.